CompletedNot Applicable

Immunomodulatory Effect of Pleuran in Children With Recurrent Respiratory Tract Infections

Czechia, Serbia, Slovakia217 participantsStarted 2023-09-25

Plain-language summary

International, multicentre, prospective, randomized, double-blind, placebo-controlled study with a food supplement Imunoglukan P4H® chewable tablets to evaluate preventive effect on reduction of respiratory tract infections (RTIs) in children with a history of recurrent respiratory tract infections (RRTIs) in the previous infectious season prior enrolment. Participants or their guardians will record the incidence and duration of RTIs in the Patient diary for 3 months.

Who can participate

Age range3 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * signed informed consent * age 3-18 years * history of recurrent respiratory infections: * Age 3 to 5 years (\< 6 years): 6 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023 * Ages 6 to 18 years (≥ 6 years): more than 3 upper or lower respiratory tract infections from October 2022 until the end of March 2023 Exclusion Criteria: * refused informed consent * bronchopulmonary dysplasia * primary immunodeficiency * cystic fibrosis * chronic diarrhoea * chronic diseases of the lungs, kidneys and liver * malformations of the cardiovascular system * oncological disease * malnutrition * intolerance to any of the ingredients in the study product * taking preventive immunomodulatory therapy (beta-glucans, bacterial lysates, isoprinosine) less than 14 days prior enrolling the patient into the study

What they're measuring

change in the number of RTIs episodes (total number)

Timeframe: change in the number of RTIs episodes (total number) during 3 month supplementation (from enrollment to the end of the treatment at 3 months)

Trial details

NCT IDNCT06974747

SponsorPleuran, s.r.o.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-31